SWISS_EVIDENCE - Compartment Compressibility Monitoring Using CPM#1

NCT ID: NCT05367921

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2022-05-17

Brief Summary

Compartment syndrome is a very serious musculoskeletal disorder, which can lead to potentially devastating consequences, such as limb amputation and life-threatening conditions. It is a well described medical condition considered to be an orthopaedic emergency affecting all ages.

Even though compartment syndrome is a well described medical condition, the appropriate treatment (i.e., fasciotomy to release tissue pressure) is invasive and involves its own risks. Furthermore, and of most critical importance is the timing for the intervention of a fasciotomy. The concerned limb may already have had severe, sometimes even irreversible, tissue damage due to high intra-compartmental pressure within 6 to 10 hours.

The standard diagnostic method for compartment syndrome is an invasive intra-compartmental pressure measurement via insertion of a pressure monitoring device into the muscle compartment. Commercially available intra compartmental pressure monitors have a highly variable intra-observer reproducibility and user errors are common.

Compared to the invasive modalities, the Compremium Compartmental Compressibility Monitoring System (CPM#1) shows promising advantages for the clinical application. Not only is the technology used for the CPM#1 device safe and non-invasive for the patient with minimal training required for the healthcare professionals, but it has also demonstrated high intra- and inter-observer reproducibility (as per bench tests and clinical settings with prototypes, to be confirmed in clinical studies like this one). The use of the CPM#1 device therefore facilitates the measurements, as it is based on pre-existing ultrasound methods and avoids any further risks to the patients compared to invasive compartmental pressure diagnosis methods.

Conditions

Compartment Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CPM#1

Compartment compressibility ratio measurement using the CPM#1 device

Group Type: EXPERIMENTAL

Measurement of compartment compressibility

Intervention Type: DEVICE

Application of the CPM#1 device for compartment compressibility ratio measurement - 4 measurements on both legs of each healthy volunteer will be performed

Interventions

Measurement of compartment compressibility

Application of the CPM#1 device for compartment compressibility ratio measurement - 4 measurements on both legs of each healthy volunteer will be performed

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers
• Male and female
• Age between 18 and 84

Exclusion Criteria

• Previous surgery to or fracture of the lower leg
• Peripheral arterial or venous disease
• History of compartment syndrome
• Limb anomalies
• General muscle disorder
• Participants under the influence of excessive alcohol, consumption of narcotics or benzodiazepines prior to procedure
• Participants under the effect of analgesic (< 12 hours)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Compremium AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helen Anwander, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department für Orthopädie und Traumatologie, Inselspital Bern

Locations

Universitätsklinik für Orthopädische Chirurgie und Traumatologie Inselspital

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

SWISS_EVIDENCE

Identifier Type: -

Identifier Source: org_study_id